S T A T E O F N E W Y O R K
________________________________________________________________________
2132--B
2023-2024 Regular Sessions
I N A S S E M B L Y
January 23, 2023
___________
Introduced by M. of A. DINOWITZ, BORES, SIMON -- read once and referred
to the Committee on Higher Education -- committee discharged, bill
amended, ordered reprinted as amended and recommitted to said commit-
tee -- recommitted to the Committee on Higher Education in accordance
with Assembly Rule 3, sec. 2 -- committee discharged, bill amended,
ordered reprinted as amended and recommitted to said committee
AN ACT to amend the education law, in relation to the automated storage
and dispensing of controlled substances using an automated dispensing
device
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Section 6802 of the education law is amended by adding a
new subdivision 30 to read as follows:
30. "AUTOMATED DISPENSING DEVICE (ADD)" SHALL MEAN A MECHANICAL SYSTEM
USED IN NURSING HOMES AND RESIDENTIAL HEALTH CARE FACILITIES LICENSED
PURSUANT TO ARTICLE TWENTY-EIGHT OF THE PUBLIC HEALTH LAW AND HOSPICES
CERTIFIED PURSUANT TO ARTICLE FORTY OF THE PUBLIC HEALTH LAW, THAT PACK-
AGES AND LABELS PATIENT SPECIFIC MEDICATION OR MULTIPLE MEDICATIONS FOR
THE PURPOSES OF ADMINISTRATION BY A HEALTH CARE PROFESSIONAL LICENSED TO
ADMINISTER MEDICATIONS BY THE STATE OF NEW YORK BASED ON A PRESCRIPTION
OR ORDER THAT HAS COMPLETED FINAL VERIFICATION BY A LICENSED PHARMACIST.
§ 2. The education law is amended by adding a new section 6809 to read
as follows:
§ 6809. AUTOMATED STORAGE AND DISPENSING OF MEDICATIONS. 1. FOR
PURPOSES OF THIS SECTION, "AUTOMATED DISPENSING DEVICE (ADD)" SHALL HAVE
THE SAME MEANING AS SUBDIVISION THIRTY OF SECTION SIXTY-EIGHT HUNDRED
TWO OF THIS ARTICLE.
2. THE ADD AND ITS CONTENTS SHALL REMAIN THE PROPERTY OF A PHARMACY
REGISTERED UNDER THIS ARTICLE. THE PHARMACY SHALL MAINTAIN ALL
CONTROLS, RECORD KEEPING AS REQUIRED BY ALL LAWS, RULES AND REGULATIONS
OF THE STATE. PHARMACIES UTILIZING AUTOMATED DISPENSING DEVICES AS
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD00901-05-3
A. 2132--B 2
PERMITTED UNDER THIS SECTION FOR ROUTINE MEDICATION DISPENSING OF
CONTROLLED SUBSTANCES SHALL OBTAIN A MACHINE-SPECIFIC FEDERAL DRUG
ENFORCEMENT ADMINISTRATION (DEA-ADD) REGISTRATION NUMBER, AND THE APPRO-
PRIATE NEW YORK STATE LICENSING.
3. THE PHARMACY SHALL MAINTAIN RECORDS ON SITE AT THE PHARMACY (HARD
COPY OR ELECTRONIC) FOR NOT LESS THAN TEN YEARS, INCLUDING BUT NOT
LIMITED TO:
A. DOCUMENTATION OF THE APPROVAL FOR USE AND PLACEMENT OF THE ADD
RECEIVED FROM THE DEPARTMENT AND/OR THE BOARD OF PHARMACY;
B. DELIVERY MANIFESTS OR SIMILAR ELECTRONIC DOCUMENTATION THAT MONI-
TORS THE TRANSPORT OF CONTROLLED SUBSTANCES BETWEEN THE PHARMACY AND
ADD;
C. ADD CLEANING AND MAINTENANCE LOGS OR SIMILAR DOCUMENTATION;
D. RECORDS AND/OR ELECTRONIC DATA OF ALL EVENTS INVOLVING THE ADD
INCLUDING BUT NOT LIMITED TO:
(I) IDENTITY OF ALL PERSONNEL WHO ACCESS THE CONTENTS;
(II) LOCATION OF THE SYSTEM ACCESSED;
(III) TYPE OF TRANSACTION WITH DATE/TIME STAMP;
(IV) NAME, STRENGTH, DOSAGE FORM, AND QUANTITY OF THE ACCESSED MEDICA-
TION;
(V) NAME OR OTHER IDENTIFIER OF THE PATIENT FOR WHOM THE MEDICATION
WAS ORDERED;
(VI) RECONCILIATION OF ALL CONTROLLED SUBSTANCE INVENTORIES AT LEAST
MONTHLY.
4. THE PREPACKAGED CARTRIDGES OR CONTAINERS MAY BE SENT TO A REMOTE
SITE TO BE LOADED INTO SUCH MACHINE BY PERSONNEL DESIGNATED BY THE PHAR-
MACIST-IN-CHARGE PROVIDED:
A. THE INDIVIDUAL CARTRIDGES OR CONTAINERS ARE TRANSPORTED TO SUCH
REMOTE SITE IN A SECURE, TAMPER-EVIDENT CONTAINER; AND
B. THE AUTOMATED PHARMACY SYSTEM USES BAR-CODING, MICROCHIP, OR OTHER
TECHNOLOGIES TO ENSURE THAT THE CONTAINERS ARE ACCURATELY LOADED IN THE
AUTOMATED PHARMACY SYSTEM.
5. ACCESS TO AN ADD SHALL BE RESTRICTED TO AUTHORIZED PHARMACY AND
FACILITY NURSING LICENSED PERSONNEL, REGISTERED PHARMACY TECHNICIANS,
AND PHARMACY AIDES AS ESTABLISHED BY THE FACILITY ADMINISTRATION IN
CONJUNCTION WITH THE PHARMACIST-IN-CHARGE. A LIST OF SUCH AUTHORIZED
PERSONNEL SHALL BE MAINTAINED AT ALL TIMES WITHIN THE SYSTEM AND SHALL
BE REVIEWED AND UPDATED PERIODICALLY.
6. ALL MEDICATIONS, INCLUDING CONTROLLED SUBSTANCES SHALL BE DISPENSED
FROM AN AUTOMATED DISPENSING DEVICE PURSUANT TO A VALID, PATIENT-SPECIF-
IC PRESCRIPTION OR ORDER.
7. THE PHARMACY AND THE FACILITY SHALL IMPLEMENT AND MAINTAIN
ADEQUATE AND APPROPRIATE POLICIES, PROCEDURES AND QUALITY ASSURANCE
PROGRAMS TO ENSURE SAFETY, ACCURACY, SECURITY, ACCOUNTABILITY, PATIENT
CONFIDENTIALITY, AND FUNCTIONALITY WITH RESPECT TO ADMINISTRATION AND
USAGE OF ADD.
8. THE ADD WILL BE MONITORED AT THE FACILITY CONTINUOUSLY BY VIDEO AND
UNDER VISUAL SUPERVISION BY A PHARMACIST DURING THE LOADING PROCESS.
9. ANY LOSSES OF MEDICATION SHALL BE REPORTED IN ACCORDANCE WITH THE
REQUIREMENTS OF THE SERVICING PHARMACY'S LICENSING BODY.
§ 3. This act shall take effect on the sixtieth day after it shall
have become a law.